Senior Supplier Quality Lead, Contract Manufacturing

Endologix; Minneapolis (MN); On-site; USD 135,000 - 158,000; Full time

Benefits offered by this job

Equity participation

401(k) with company match

Health, dental, and vision insurance

HSAs/FSAs

Generous paid time off

Job summary

Endologix LLC is seeking a Staff Supplier Quality, CM to lead contract manufacturer quality programs, onboarding, and governance. You will partner with R&D, Design Assurance, and Regulatory to translate product requirements into robust supplier controls and drive successful transfers.

The role focuses on risk-based validation, commissioning of new equipment, and ongoing oversight across manufacturing partners to ensure patient safety and compliance.

Qualifications

• Bachelor’s degree in engineering or related technical discipline required.
• 10+ years of progressive experience in supplier quality or related fields.
• Experience with ISO 13485, FDA QMSR/21 CFR Part 820, and risk management.
• Experience leading complex product or manufacturing transfers and supplier changes.

Responsibilities

• Lead CM qualification, onboarding, governance, and oversight for product quality and supply continuity.
• Provide technical quality leadership for product, process, and transfer activities to CM partners.
• Collaborate with R&D, Design Assurance, and Regulatory to align supplier controls with requirements.
• Establish and maintain CM quality oversight model including plans, agreements, and governing routines.
• Lead risk-based validation, IQ/OQ/PQ/PPQ, and validated state maintenance.

Skills

Contract manufacturer knowledge

Quality leadership

Transfer planning

Risk-based decision making

Technical communication

Education

Bachelor’s degree in engineering or related technical field

Master’s degree preferred

Tools

QMS systems

Job description

Endologix LLC is seeking a Staff Supplier Quality, CM to lead contract manufacturer quality programs, onboarding, and governance. You will partner with R&D, Design Assurance, and Regulatory to translate product requirements into robust supplier controls and drive successful transfers.

The role focuses on risk-based validation, commissioning of new equipment, and ongoing oversight across manufacturing partners to ensure patient safety and compliance.